Depuy INHANCE Stemless IDE - Clinical Trial

What is the Purpose of this Study?

This study does not require much extra time from patients, but doctors will check on them closely for two years. People in the study are placed into groups by chance. Two out of every three people will get the new shoulder device, and one out of three will get the regular device that uses a stem.

What is the Condition Being Studied?

This study is looking at a new shoulder replacement device that does not use a long metal rod inside the arm bone. These devices are called stemless prostheses. They are made for people who have very bad shoulder arthritis and sometimes tears in the rotator cuff.

Who Can Participate in the Study?

People can join this study if they are older than 55 years. They must have shoulder arthritis or a rotator cuff tear that cannot be treated in other ways. They cannot join if they have cancer, serious mental health problems, or a chronic pain condition.

Age Group
Adults

What is Involved?

This study is being done to see if a new stemless reverse shoulder device works as well as or better than the shoulder replacements that are used now. Researchers hope the new device may lead to shorter surgeries, fewer problems, and better results for patients.

Study Details

Full Title
Randomized, Prospective, Multi-Center Study of the INHANCE Stemless Total Reverse Shoulder System
Principal Investigator
Tally E. Lassiter Jr., MD, MHA
Sports Medicine Orthopaedic Surgeon
Protocol Number
IRB: PRO00117873
NCT: NCT06323980
Phase
Phase N/A
ClinicalTrials.gov
Enrollment Status
Open for Enrollment
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